Transcript

Package leaflet: Information for the user
Pregabalin Lupin 25 mg hard capsules
Pregabalin Lupin 50 mg hard capsules
Pregabalin Lupin 75 mg hard capsules
Pregabalin Lupin100 mg hard capsules
Pregabalin Lupin 150 mg hard capsules
Preagbalin Lupin 200 mg hard capsules
Pregabalin Lupin 225 mg hard capsules
Pregabalin Lupin 300 mg hard capsules
Pregabalin
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or your
pharmacist.
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Pregabalin capsules are and what they are used for
2. What you need to know before you take Pregabalin
capsules
3. How to take Pregabalin capsules
4. Possible side effects
5. How to store Pregabalin capsules
6. Contents of the pack and other information
1. What Pregabalin capsules are and what they are used
for
Pregabalin capsules belong to a group of medicines used to
treat epilepsy and Generalised Anxiety Disorder (GAD) in
adults.
Epilepsy: Pregabalin capsules are used to treat a certain
form of epilepsy (partial seizures with or without secondary
generalisation) in adults. Your doctor will prescribe
Pregabalin capsules for you to help treat your epilepsy when
your current treatment is not controlling your condition. You
should take Pregabalin capsules in addition to your current
treatment. Pregabalin capsules are not intended to be used
alone, but should always be used in combination with other
anti-epileptic treatment.
Generalised Anxiety Disorder: Pregabalin capsules are used
to treat Generalised Anxiety Disorder (GAD). The symptoms
of GAD are prolonged excessive anxiety and worry that
are difficult to control. GAD can also cause restlessness or
feeling keyed up or on edge, being easily fatigued (tired),

having difficulty concentrating or mind going blank, feeling
irritable, and having muscle tension or sleep disturbance.
This is different to the stresses and strains of everyday life.
2. What you need to know before you take Pregabalin
capsules
Do not take Pregabalin capsules
If you are allergic to pregabalin or any of the other ingredients
of this medicine (listed in section 6).
Warnings and Precautions
• Some patients taking Pregabalin capsules have reported
symptoms s uggesting an allergic reaction. These
symptoms include swelling of the face, lips, tongue, and
throat, as well as diffuse skin rash. Should you experience
any of these reactions, you should contact your physician
immediately.
• Pregabalin capsules has been associated with dizziness
and somnolence, which could increase the occurrence
of accidental injury (fall) in elderly patients. Therefore,
you should be careful until you are used to any effect the
medicine might have.
• Pregabalin capsules may cause blurring or loss of vision,
or other changes in eyesight, many of which are temporary.
You should immediately tell your doctor if you experience
any changes in your vision.
• Some patients with diabetes who gain weight while
taking pregabalin may need an alteration in their diabetic
medicines.
• Certain side effects may be more common, such as
sleepiness, because patients with spinal cord injury may
be taking other medicines to treat, for example, pain or
spasticity, that have similar side effects to pregabalin and
the severity of these effects may be increased when taken
together.
• There have been reports of heart failure in some patients
when taking Pregabalin capsules; these patients were
mostly elderly with cardiovascular conditions. Before
taking this medicine you should tell your doctor if you
have a history of heart disease.
• There have been reports of kidney failure in some patients
when taking Pregabalin capsules. If while taking Pregabalin
capsules you notice decreased urination, you should tell
your doctor as stopping the medicine may improve this.
• A small number of people being treated with antiepileptics such as Pregabalin capsules have had thoughts
of harming or killing themselves. If at any time you have
these thoughts, immediately contact your doctor.
• When Pregabalin capsules are taken with other medicines
that may cause constipation (such as some types of pain
medicines) it is possible that gastrointestinal problems may
occur (e.g., constipation, blocked or paralysed bowel).
Tell your doctor if you experience constipation, especially

if you are prone to this problem.
• Before taking this medicine you should tell your doctor
if you have a history of alcoholism or drug abuse
or dependence. D o n o t t a k e m ore medicine than
prescribed.
• There have been reports of convulsions when taking
Pregabalin capsules or shortly after stopping Pregabalin
capsules. If you experience a convulsion, contact your
doctor immediately.
• There have been reports of reduction in brain function
(encephalopathy) in some patients taking Pregabalin
capsules when they have other conditions. Tell your doctor
if you have a history of any serious medical conditions,
including liver or kidney disease.
Children and adolescents
The safety and efficacy in children and adolescents (under
18 years of age) has not been established and therefore,
pregabalin should not be used in this age group.
Other medicines and Pregabalin capsules
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Pregabalin capsules and certain other medicines may influence
each other (interact). When taken with certain other medicines,
Pregabalin capsules may potentiate the side effects seen with
these medicines, including respiratory failure and coma. The
degree of dizziness, sleepiness and decreased concentration
may be increased if Pregabalin capsules are taken together
with medicinal products containing:
Oxycodone – (used as a pain-killer)
Lorazepam – (used for treating anxiety)
Alcohol
Pregabalin capsules may be taken with oral contraceptives.
Pregabalin capsules with food, drink and alcohol
Pregabalin capsules may be taken with or without food.
It is advisable not to drink alcohol while taking Pregabalin
capsules.
Pregnancy and breast-feeding
Pregabalin capsules should not be taken during pregnancy or
when breast-feeding, unless you are told otherwise by your
doctor. Effective contraception must be used by women of
child-bearing potential. If you are pregnant or breast-feeding,
think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
Pregabalin capsules may produce dizziness, sleepiness and
decreased concentration. You should not drive, operate
complex machinery or engage in other potentially hazardous
activities until you know whether this medicine affects your

ability to perform these activities.
3. How to take Pregabalin capsules
Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
Your doctor will determine what dose is appropriate for you.
Pregabalin capsules are for oral use only.
Epilepsy o r Generalised Anxiety Disorder:
• Take the number of capsules as instructed by your doctor.
• The dose, which has been adjusted for you and your
condition, will generally be between 150 mg and 600 mg
each day.
• Your doctor will tell you to take Pregabalin capsules either
twice or three times a day. For twice a day take Pregabalin
capsules once in the morning and once in the evening,
at about the same time each day. For three times a day
take Pregabalin capsules once in the morning, once in the
afternoon and once in the evening, at about the same time
each day.
If you have the impression that the effect of Pregabalin capsules
is too strong or too weak, talk to your doctor or pharmacist.
If you are an elderly patient (over 65 years of age), you
should take Pregabalin capsules normally except if you have
problems with your kidneys.
Your doctor may prescribe a different dosing schedule and/or
dose if you have problems with your kidneys.
Swallow the capsule whole with water.
Continue taking Pregabalin capsules until your doctor tells
you to stop.
If you take more Pregabalin capsules than you should
Call your doctor or go to the nearest hospital emergency unit
immediately. Take your box or bottle of Pregabalin capsules
with you. You may feel sleepy, confused, agitated, or restless
as a result of taking more Pregabalin capsules than you should.
If you forget to take Pregabalin capsules
It is important to take your Pregabalin capsules regularly at
the same time each day. If you forget to take a dose, take it as
soon as you remember unless it is time for your next dose. In
that case, just carry on with the next dose as normal. Do not
take a double dose to make up for a forgotten dose.
If you stop taking Pregabalin capsules
Do not stop taking Pregabalin capsules unless your doctor
tells you to. If your treatment is stopped it should be done
gradually over a minimum of 1 week.
After stopping long and short-term Pregabalin capsules
treatment, you need to know that you may experience certain
side effects. These include, trouble sleeping, headache,
nausea, feeling anxious, diarrhoea, flu- like symptoms,

Certain side effects may be more common, such as sleepiness,
because patients with spinal cord injury may be taking other
medicines to treat, for example, pain or spasticity, that have
similar side effects to pregabalin and the severity of these
effects may be increased when taken together
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet.
You can also report side effects directly via the Yellow
Card Scheme, website: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Pregabalin capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the carton or bottle. The expiry date refers to the last day
of that month.
Store below 25°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Pregabalin capsules contains
The active substance is pregabalin.
Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100
mg, 150 mg, 200 mg, 225 mg or 300 mg pregabalin.
The other ingredients are:
pregelatinised starch, talc, gelatine, titanium dioxide (E171),
sodium lauryl sulphate, black ink, (which contains shellac
(E904) and black iron oxide (E172)).
The 75, 100, 200, 225 and 300 mg capsules also contain red
iron oxide (E172).
What Pregabalin capsules looks like and contents of the
pack
Size ‘4’ capsules with white cap and
25 mg capsules white body, imprinted with “PG” on cap
and “25” on body in black ink, containing
white to off white powder.
Size ‘4’ capsules with white cap and
50 mg capsules white body, imprinted with “PG” on cap
and “50 and band” on body in black ink,
containing white to off white powder.

75 mg capsules

100 mg capsules

150 mg capsules

200 mg capsules

225 mg capsules

300 mg capsules

Size ‘4’ capsules with dark brown cap and
white body, imprinted with “PG” on cap
and “75” on body in black ink, containing
white to off white powder.
Size ‘3’ capsules with dark brown cap and
dark brown body, imprinted with “PG”
on cap and “100” on body in black ink,
containing white to off white powder.
Size ‘2’ capsules with white cap and white
body, imprinted with “PG” on cap and
“150” on body in black ink, containing
white to off white powder.
Size ‘1’ capsules with light brown cap and
light brown body, imprinted with “PG”
on cap and “200” on body in black ink,
containing white to off white powder.
Size ‘1’ capsules with light brown cap
and white body, imprinted with “PG”
on cap and “225” on body in black ink,
containing white to off white powder.
Size ‘0’ capsules with dark brown cap and
white body, imprinted with “PG” on cap
and “300” on body in black ink, containing
white to off white powder.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.